Kornimate/medical-research-clean huggingface dataset:
prevalence of atrial delay that would preclude optimization of atrioventricular (av) delay in patients with biventricular (biv) device

Conditions: Heart Failure

Summary: the purpose of this study is to determine the proportion of patients who are undergoing biventricular (biv) implantable cardioverter defibrillator (icd) implantation in whom optimization of atrioventricular (av) delay is not possible due to prolonged inter-atrial/intra-atrial delay. these patients would benefit from left atrial pacing, and if a significant number of patients fall into this group, it may be beneficial to develop a left atrial lead.

this is a prospective observational study. patients referred for biv-icd implantation or upgrade will be implanted as is routinely done, with the following modifications: * electrical readings will be taken at various points in the procedure. * the ra lead will temporarily be placed on the atrial septum for these readings (normally it is actively fixed to the ra appendage wall). the final ra lead position will be actively fixed to the ra appendage wall as is standard practice. * the cs lead will be placed in the proximal coronary sinus for these readings prior to passing it distally to pace the lv. * patients will undergo transthoracic echocardiography (tte) 30 days post-procedure. this will be coordinated to coincide with their standard 30-day follow-up appointment. conduction times between the left atrium and right atrium (inter-atrial conduction time) will be measured at the time of implant, and left atrial contraction time will be measured by tte at the follow-up appointment. for patients in whom the inter-atrial conduction time plus the left atrial contraction time is greater than the right-atrial to right-ventricular conduction time, it is not possible to optimize the av delay. the proportion of patients who fall into this group will be the main endpoint of the study. patients will be followed for this study until their follow-up appointment and tte at 30 days post-implant. the total sample size of this study will be 50 patients. we expect to consent approximately 75 patients, expecting that 1/3 will not meet all entrance criteria or will withdraw early.

Eligibility criteria:
inclusion criteria: * age 18 or older * have the ability to provide informed consent and willingness to comply with follow-up tests * qrs duration \> 120 ms * ejection fraction \< 35% * persistent symptoms of class iii or iv heart failure despite a stable and optimized medical regimen * normal sinus rhythm or sinus bradycardia exclusion criteria: * white-parkinson-white syndrome * chronic persistent atrial fibrillation * complete heart block

Keywords: biventricular icd av delay
mediterranean diet intervention to improve gastrointestinal function in parkinson's disease a randomized, controlled, clinical trial

Conditions: Parkinson Disease

Summary: this is a 10-week randomized, controlled study to investigate the effect of a mediterranean diet intervention on gastrointestinal function in parkinson's disease. after a 2-week run-in period, participants will be instructed to receive standard of care for constipation or receive standard of care + follow a mediterranean diet for 8 weeks and answer daily and weekly questionnaires. nutritional and neurological evaluations and stool samples will be collected at 0, 4 and 8 weeks.


Eligibility criteria:
inclusion criteria: * physician-diagnosed parkinson's disease aged 40-85 years * drug naïve or on stable dosage of parkinson's medications with no plans to change for the duration of the study protocol * hoehn \& yahr stage =\<2.5 in the clinical "on" state * constipation syndrome scores \>=2.0 based on the gsrs * consume \<20 grams of fiber daily based on the block fruit/vegetable/fiber screener * able to complete informed consent in english * willing to maintain habitual diet through the pre-baseline period. * willing to make dietary changes to follow a mediterranean diet and/or receive standard of care for constipation during the intervention period. * willing to complete daily and weekly questionnaires and 12 dietary recalls over approximately 10 weeks. * able to provide stool samples during the study collection periods. * willing to avoid strenuous exercise and alcohol such as beer, wine, and cocktails 24 hours prior to each of the 3 study visits. * able to fast (no food or drink, except water, or decaf tea) at least 12 hours before each study visit * willing to discontinue taking prebiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol. exclusion criteria: * atypical or secondary parkinsonism * underweight (bmi \<18.5) * history of deep brain stimulation (dbs) surgery * regular use of enemas or suppositories to alleviate constipation (e.g., \>1 time per week) * use of another investigational product within 3 months of the screening visit * antibiotic or probiotic supplement use within 2 months from the day of stool collection * currently being treated for a physician-diagnosed gi disease or condition other than constipation, irritable bowel disease, gastroparesis, reflux or diverticular disease

Keywords: mediterranean diet microbiome constipation inflammation
efficacy evaluation of normothermic perfusion machine preservation in liver transplant using very old donors

Conditions: Ischemic Reperfusion Injury

Summary: the purpose of this study is to evaluate the impact of normothermic machine perfusion in liver transplantation using grafts of brain death donors older or equal than 70 years

mean donor age for liver transplantation in tuscany, italy, is increasing and is actually 71 years. old donors are a valuable resource but their use has been related to a major incidence of primary non function (pnf), delayed graft function (dgf) and ischemic type biliary lesions (itbl). ischemia-reperfusion injury is a major reason for the development of these complications and and old grafts are more susceptible than younger ones. normothermic machine perfusion (nmp) is a novel and promising technique that allows preservation in a more physiological environment. it is our belief that the use of nmp might reduce the impact of ischemia-reperfusion injuries in older grafts thus reducing the incidence of complications and providing a better outcome.

Eligibility criteria:
inclusion criteria: * patient on waiting list for liver transplant * signed informed consent * age between 18 and 70 * eligibility for liver transplant as for university of pisa liver transplant center protocol * capacity and willingness to participate to the protocol exclusion criteria: * no signed informed consent * age under 18 or over 70 * presence of disease that may influence results * patient participation to other studies * re-liver transplant * abo incompatible olt * multiorgan transplant * liver transplant for acute liver failure or trauma * meld (model for end stage liver disease) \>24 * patient not suitable to participate on investigators's opinion

Keywords: normothermic perfusion old donors extended criteria grafts reconditioning
clinical evaluation of the standard™ q malaria/crp duo test

Conditions: Fever Malaria

Summary: the aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the standard™ q malaria/crp duo test when used by health care workers (hw) in a point of care (poc) setting in malaria endemic areas in india. performance will be assessed in comparison with expert microscopy as the reference test for malaria, and with a high quality, commercially available c-reactive protein (crp) test kit run on a laboratory machine as a reference test for crp.


Eligibility criteria:
inclusion criteria: * clinically suspected malaria on the basis of fever or history of fever in the previous 72 h * age ≥ 5 years, (iii) having been informed of the study and signed a written consent form exclusion criteria: * signs of severe malaria or other severe disease * patients not fulfilling the inclusion criteria.

Keywords: malaria fever c-reactive protein point-of-care testing
the effect of late night meals on fasting glucose in type 2 diabetes patients

Conditions: Fasting Hyperglycemia

Summary: high fasting glucose is a very common problem in type 2 diabetic patients. the cause is probably glucose production by the liver, known as the "dawn phenomenon". the investigators hypothesize that a late night meal can lower the fasting glucose level by early morning insulin secretion stimulated by the food. in this study the investigators intend to test the effect of different kinds of late night meals on fasting glucose in type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus with hba1c 6.5-9%, fasting glucose of 126-200 mg/dl and bmi of 27-40. exclusion criteria: * patient treated with insulin, glp-1 analog or weight reduction medications. * type 1 diabetes * pregnancy * renal failure (creatinin \>1.4 for male and 1.3 for female * uncontrolled hypertension (\>160/100) * abnormal thyroid function test * patient treated with steroids or psychiatric medications.
the effects of oxytocin and vasopressin on delta-beta cross-frequency coupling

Conditions: Healthy

Summary: the main aim of the study is to investigate whether intranasal oxytocin and vasopressin have effects on delta-beta cross-frequency coupling under resting-state and task conditions.

a double-blinded, placebo-controlled, between-subject design is employed in this study. in a randomized order, a total of 120 healthy males and females are instructed to self-administer intranasal spray of oxytocin, vasopressin, or placebo. (1) 15-minute resting-state eeg data are collected 35 minutes after treatment. (2) participants complete tasks including stroop, go/nogo, and anxiety induction with behavioral (response time, accuracy, or rating) and eeg data being collected. personality traits of subjects are assessed using validated chinese version questionnaires including the beck depression inventory (bdi-ii), state-trait anxiety inventory (stai), autism spectrum quotient (asq), and adult adhd self-report scale (asrs-v1.1). participants are asked to complete positive and negative affect schedule (panas) when they just arrive, before resting state and after the tasks. three blood samples (5 ml) are collected into 6 ml etda tubes when participants just arrive, before resting state recording and after all of the tasks.

Eligibility criteria:
inclusion criteria: * healthy subjects without past or current psychiatric or neurological disorders. exclusion criteria: * history of head injury. * pregnant,menstruating,taking oral contraceptives. * medical or psychiatric illness.

Keywords: oxytocin vasopressin delta-beta coupling
second opinions in oncology

Conditions: Breast Cancer; Pancreatic Cancer; Colorectal Cancer

Summary: the long-time goal is to understand what decision-making process and patient characteristics factor into a patient deciding to stay with their initial physician versus seeking treatment with a second opinion.

the long-time goal is to understand what decision-making process and patient characteristics factor into a patient deciding to stay with their initial physician versus seeking treatment with a second opinion. to do this, the pi will examine the second opinion retention rates and patient characteristics of three distinct populations: breast cancer patients, pancreatic cancer patients and colorectal cancer patients. the study team hypothesize the majority of breast cancer and colorectal cancer patients who seek a second opinion at the university of colorado, will preferentially choose to return to their first provider, whereas patients with pancreatic cancer who seek a second opinion at the sponsor's institution will be more likely to go on to receive care at the university of colorado. the pi predicts the difference in second opinion retention rates between these three populations is due to the ability of the second opinion pancreatic cancer provider's ability to offer more treatment or a different treatment plan at the sponsor institution relative to the patient's first provider. the study team also predict that socioeconomic status and education will have a positive correlation with changing to with a second opinion physician whereas geographic distance and treatment plan similarity will have a negative correlation. the study team will assess this hypothesis by conducting a retrospective cohort study of breast, pancreatic, and colorectal cancer patients who received a second opinion at the university of colorado. from this cohort, the study team will identify patients who both received their care at the sponsor institution and patients who returned to their initial provider to receive care. the study team will invite these patients to participate in semi-structured interviews to better understand how and why the patient made their treatment decisions.

Eligibility criteria:
inclusion criteria: * cancer patients who are 18 years of age or older who received a second opinion at the university of colorado. * a subset of these patients will be invited to participate in semi-structured interviews exclusion criteria: * patients under the age of 18. * patients who did not receive a second opinion at the university of colorado.
registry of patients diagnosed with lysosomal storage diseases

Conditions: Mucopolysaccharidosis I; Mucopolysaccharidosis II; Mucopolysaccharidosis IV A; Mucopolysaccharidosis VI; Mucopolysaccharidosis VII; Pompe Disease Infantile-Onset; Neuronopathic Gaucher Disease; Wolman Disease

Summary: this is an international prospective and retrospective registry of patients with lysosomal storage diseases (lsds) to understand the natural history of the disease and the outcomes of fetal therapies, with the overall goal of improving the prenatal management of patients with lsds.

the need for methods to track patient outcomes, clinical management, medical decision making, and quality of care are all part of current national mandates in patient safety and quality of care delivery. the aim of this registry is to prospectively and retrospectively collect data on patients who are diagnosed with lysosomal storage disease and other lsd mutations. data collected will be used to: 1. identify patient outcomes of therapies. 2. improve clinical management of patients with lsds. 3. improve medical decision making. 4. improve quality of care.

Eligibility criteria:
inclusion criteria: * patients aged 0-64 with a diagnosis of a lysosomal storage disease * pregnant patients whose fetus has a diagnosis of a lysosomal storage disease exclusion criteria: * there are no current exclusion criteria

Keywords: lysosomal storage disease lsds inborn error of metabolism hurler syndrome sly syndrome hunter syndrome mucopolysaccharidosis i mucopolysaccharidosis ii mucopolysaccharidosis iva mucopolysaccharidosis vi mucopolysaccharidosis vii pompe disease infantile-onset neuronopathic gaucher disease wolman disease mps mucopolysaccharidosis
haemodynamic response to general anaesthesia in healthy orthopaedic patients

Conditions: Hypotension

Summary: continuous cardiovascular monitoring as part of management of high-risk surgical patients is widely practiced, however its role in low-risk surgical patients is unclear. detailed monitoring of cardiovascular parameters from pre-induction stage allows clinicians to individualise anaesthetic management in the perioperative period. the investigators' aim was to investigate haemodynamic and bispectral index (bis) changes in healthy patients undergoing surgery following induction of anaesthesia with propofol using a continuous non-invasive blood pressure device (lidcorapid™).

recruitment orthopaedic surgical teams, anaesthetists and theatre staff were made aware of the study that was being conducted at the investigators' institution. prospective subjects that met the inclusion criteria were identified from the hospital operating theatre's database two weeks prior to surgery. a letter, which contained the study's objectives and methods, was sent out to all patients. subsequently, a telephone call was made to patients one week before surgery to clarify any queries they had. consent was obtained on the morning of surgery. all study participants provided written informed consent. peri-operative monitoring lidco™ cnap and bis monitoring were attached prior to induction of anaesthesia in the anaesthetic room of the operating theatre. a standardised anaesthetic technique was used for every participant, consisting of propofol induction, sevoflurane maintenance to a target bis (40-60) and opioid analgesia with fentanyl. participants underwent positive pressure ventilation to a tidal volume of 8ml/kg. measurements of the following variables were taken continuously from pre-induction to time of extubation: heart rate, mean arterial blood pressure, stroke volume, cardiac output, systemic vascular resistance and bis. data recorded up to 3 minutes following propofol injection was analysed to capture the post-induction period. further measurements were taken in recovery room. the total quantity and type of fluids, drugs administered, time of tourniquet application and removal (if performed), and the duration of the operation were recorded.

Eligibility criteria:
inclusion criteria: * patients included in the study were those aged 18-45 years undergoing elective lower limb arthroscopic procedures with an american society of anesthesiologists (asa) grade of i-ii. exclusion criteria: * patients unable or unwilling to provide valid informed consent, * patients undergoing regional anaesthesia, * patients that have contraindications to the lidco rapid™ cnap monitoring (cardiac arrhythmias, aortic regurgitation and digital ischaemia) and bis monitoring (hypersensitivity to adhesive use) and refusal of surgical, anaesthetic or operating theatre team.
prognostic value of progesterone on oocyte retrieval day for in vitro fertilization outcome

Conditions: Infertility; Assisted Reproductive Technology

Summary: this observational study aims the potential role of serum progesterone levels on the day of oocyte pick-up on the probability of pregnancy, in patients undergoing antagonist ivf cycles. there has been evidence, that increased serum levels of progesterone on triggering day are associated with a decreased probability of pregnancy after ivf. there is no study that investigate assocation between serum progesterone levels on the day of oocyte pick-up and ivf outcomes. this study will be the first in this case.


Eligibility criteria:
inclusion criteria: * age \< 40 years * basal fsh \< 12 iu/l * basal p \< 1.6 ng/ml exclusion criteria: * women with polycystic ovaries syndrome (pcos) * women with stage iii-iv endometriosis * women with a pathological condition of the adrenal glands
preventing post-operative delirium in patients undergoing a pneumonectomy, esophagectomy or thoracotomy

Conditions: Delirium; Cognitive Impairment; Post-traumatic Stress Disorder; Depression; Anxiety

Summary: the purpose of this study is to investigate the effectiveness of a preventative low-dose of haloperidol to prevent delirium in patients undergoing a esophagectomy, pneumonectomy or thoracotomy. delirium is state of severe confusion and some symptoms include: * cannot think clearly * have trouble paying attention * have a hard time understanding what is going on around them * may see or hear things that are not there. these things seem very real to them.

50% of patients who undergo esophageal and/or lung resection suffer from acute brain dysfunction or delirium postoperatively. delirium is a state of brain failure characterized by disturbance of consciousness with reduced ability to focus, sustain, or shift attention that occurs over a short period of time and tends to fluctuate over the course of the day. presence of delirium in the post-operative phase is associated with a longer length of both intensive care unit and hospital stay, increased health-care costs, long-term functional and cognitive decline, and an increased risk of in-hospital and post-discharge mortality. haloperidol primarily acts by blocking dopamine (d2) receptors. this dopamine blockade in the cerebral cortex improves cognition and reduces delirium. along with the dopamine blockade, haloperidol has anti-inflammatory properties. it inhibits production of lipopolysaccharide induced pro-inflammatory cytokines, interleukin (il-1) and tumor necrosis factor alpha (tnf-α). haloperidol also increases levels of interleukin -1 receptor antagonist (il-1ra), an anti-inflammatory cytokine that blocks the action of other pro-inflammatory cytokines. if unchecked, the inflammatory cytokines cause impaired concentration, sleep disturbances, and agitation the cardinal symptoms of delirium; and induce a reduction in cholinergic activity. given the inhibitory effect of acetylcholine on certain cytokines such as interleukin-6, a repetitive cycle of inadequate regulation of inflammation due to cholinergic depletion ensues. haloperidol with its anti-inflammatory properties seeks to mitigate this repetitive vicious cycle.

Eligibility criteria:
inclusion criteria: 1. at least ≥ 18 years of age and older 2. undergoing a possible or scheduled thoracotomy 3. english speaking exclusion criteria: 1. history of schizophrenia and parkinson's disease 2. history of severe dementia 3. history of alcohol abuse 4. on cholinesterase inhibitors or levodopa 5. pregnant or nursing 6. corrected qt interval \> 550 milliseconds at the time of randomization 7. history of neuroleptic malignant syndrome or haloperidol allergy

Keywords: delirium confusion surgery cognitive impairment post-traumatic stress disorder depression anxiety